Ability of Beta-glucan Supplementation to Augment Immune Function

Not Applicable

Completed

• Conditions: Cold; Cold Symptom; Supplement; Flu Symptom; Flu; Gastrointestinal Tolerance; Stress
• Interventions: Dietary Supplement: Beta-Glucan; Dietary Supplement: Placebo

• Registration Number: NCT03769012
• Lead Sponsor: Kemin Foods LC

Brief Summary

This proposed study is designed to assess the efficacy of a capsule containing beta-glucan taken orally daily as compared to a placebo capsule on the URTI symptoms, and the immune response change in marathon runners

Detailed Description

At screening, an informed consent form will be given to the potential volunteer. They will be required to read the information and will be given the opportunity to seek more information if needed or provided with the option of taking the consent form home to review prior to making their decision. If agreeable, the volunteer will sign the consent form and receive a duplicate of the signed copy. Once consent has been obtained, the screening visit will proceed. Each volunteer will be sequentially assigned a screening number to be entered in the screening and enrollment log. Screening assessments include: review medical history, assess inclusion and exclusion criteria, vitals, study diary, URTI symptom questionnaire, bowel diary, and GI symptom questionnaire.

The next visit will be scheduled 14 days prior to their marathon date (baseline). Participants will be reminded to complete URTI questionnaire, daily study diary, modified GI symptoms and bowel diary in advance of this baseline visit. At baseline participants will begin daily completion of study diaries, URTI questionnaires, daily bowel diaries, and GI tolerance questionnaires. In clinic subjects will complete mood and stress questionnaires, and blood sample for the analysis of CRP and NK cell activity. In addition, on the day of the marathon the participant will be instructed to complete a muscle soreness assessment.

Two and four weeks post-marathon participants will return to the clinic for with unused investigational product, completed study diaries, daily URTI questionnaires, daily bowel diaries, and GI tolerance questionnaires. In clinic subjects will complete mood and stress questionnaires, and blood sample for the analysis of CRP and NK cell activity.

Study Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-07
• Study Start: 2018-12-27
• Primary Completion: 2019-11-30
• Study Completion: 2020-05-30
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Males and Females 21-65 years age
2. Body Mass Index (BMI) > 18 kg/m2 to < 34.99 kg/m2
3. Willing to wash-out for nutritional supplements known to affect immune function
4. Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
5. Agree to keep lifestyle habits consistent
6. Currently registered to participate in a full marathon and on a training regimen
7. Healthy as determined by laboratory results, medical history, and physical exam
8. Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria

1. Women who are pregnant, breastfeeding, or planning to become pregnant during the occurrence of the trial
2. Verbal confirmation of previous major gastrointestinal surgery or other major digestive disorder which may interfere with the absorption of nutrients
3. Participant has a known allergy to the test material's active or inactive ingredients
4. Chronic consumption of beta-glucan supplements
5. Consumption of anti-inflammatory medications known to affect immune function
6. On antibiotics within 4 weeks of baseline
7. Currently taking antipsychotic medications
8. Prebiotics and probiotics unless on a stable regimen
9. Verbal confirmation of Type I or Type II diabetes or clinically important renal, hepatic, cardiac, pulmonary, pancreatic, neurologic, or biliary disorder, or cancer to be assessed by QI
10. Verbal confirmation of a diagnosed chronic inflammatory condition
11. Verbal confirmation of autoimmune disease or if immune-compromised
12. Chronic recurring respiratory signs and symptoms due to allergies (including seasonal allergies) or chronic bronchitis, asthma, or wheezing
13. Current or history (within past 6 months) of tobacco use
14. Consumption of >14 standard alcoholic drinks per week

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Beta-Glucan	Beta-Glucan
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Global Cold/Flu Symptom Severity Score Wisconsin Upper Respiratory Symptom Survey (WURSS)	ANOVA with 2 and 4 weeks post-marathon	AUC for cold/flu symptoms from Wisconsin Upper Respiratory Symptom Score

Secondary Outcome Measures

Name	Time	Method
C-Reactive Protein	ANOVA with 2 and 4 weeks post-marathon	Change in concentration from baseline
Gastrointestinal symptoms	ANOVA with 2 and 4 weeks post-marathon	Total gastrointestinal symptom rating score (GSRS)
Natural Killer Cell Activity	ANOVA with 2 and 4 weeks post-marathon	Change from baseline
URTI Cold/Flu Symptoms from Wisconsin Upper Respiratory Symptom Survey	ANOVA with 2 and 4 weeks post-marathon	Total number of symptoms
URTI Episodes from Wisconsin Upper Respiratory Symptom Survey	ANOVA with 2 and 4 weeks post-marathon	Total number of URTI Episodes/person
Sick days	ANOVA with 2 and 4 weeks post-marathon	Percentage of subjects with sick days
Severity of cold/flu symptoms from Wisconsin Upper Respiratory Symptom Survey	ANOVA with 2 and 4 weeks post-marathon	Total severity score (each symptom scored on scale of 0-no symptom to 7-severe symptom)
Stress Level from the perceived stress scale	ANOVA with 2 and 4 weeks post-marathon	Change from baseline on the Perceived Stress Scale

Trial Locations

Locations (1)

KGK Science Inc.; 🇨🇦 London, Ontario, Canada